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Banzel / Rufinamide

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1 Banzel / Rufinamide on Wed Sep 30, 2009 3:13 pm

TJW

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Banzel (BAN-zel) is the brand name used in the United States and some other countries for the seizure medicine rufinamide (ru-FIN-a-mide). In the United States, the Food and Drug Administration (FDA) approved rufinamide in 2008 to be used as an add-on (adjunctive) seizure medicine in children 4 years and older and adults with the Lennox-Gastaut (LGS) syndrome. The LGS is an epilepsy syndrome that usually is difficult to treat. It can comprise multiple seizure types, including atonic (drop), tonic (stiffening), tonic-clonic (stiffening and jerking), absence (staring) and other seizure types. Cognitive impairment or intellectual delay can accompany the syndrome.

For adults, the manufacturer recommends a starting dose of 200 mg twice a day, but you and your doctor may choose to start more slowly or more rapidly to fit your particular needs. Dosing can be increased by adding an extra 200 (or 400) mg twice a day every two days, to a maximum of 1600 mg twice a day (3200 mg per day total).

Children will usually be started at doses of approximately 10 mg/kg/day administered in two equally divided doses. Dosing can increase by adding additional 10 mg/kg amounts every two days, until the child is taking 45 mg/kg/day or a maximum of 3200 mg/day, divided into two doses each day.

Most people prefer to swallow the tablets whole to avoid their bitter taste. But people who are unable to swallow whole tablets can crush the tablet and mix it with food. Banzel is better absorbed when you take it with food, so this is preferred.

All forms of Banzel should be stored at room temperature, away from light and humidity and out of the reach of children. The manufacturer recommends storing Banzel at around 25° C (77° F). You may take it with you on excursions of temperatures between 15° to 30° C (59° to 86°F). The drug may be stable at greater extremes of temperature, but information is lacking.

This medication is indicated as adjunctive (add-on) therapy in the treatment of seizures associated with Lennox-Gastaut syndrome in children 4 years and older and in adults. Usually, Banzel is added when another seizure medicine is not controlling all seizures, rather than being used by itself; however, an experienced physician may choose to try Banzel as a single agent in some circumstances (so-called off-label use).

A variety of seizure types may respond to Banzel, including partial and generalized seizures. In the clinical trials an improvement in seizures was much more likely than was complete elimination of seizures, and not all patients had even an improvement.

Studies of Banzel were performed on 138 patients who had an average of at least 90 seizures per month, and were taking 1-3 other seizure medicines. Over 1-2 weeks, the Banzel dosage was increased to 45 mg/kg/day or a maximum of 3200 mg. Dose was split into two equal amounts, each given twice a day. The group given Banzel experienced a median 33% reduction in total seizures, and a 43% reduction in tonic and atonic seizures. These improvements were better than those given placebo pills.

In clinical trials, the most common side effects of Banzel were headache, dizziness, fatigue and sleepiness, double vision and tremor (trembling). The percent of people who had these side effects is given below, for people taking the highest dose (3200 mg/day). Side effects tended to be less for people on lower dosages. Some people had more than one side effect. Not all of the side effects may have been caused by Banzel, because people, for example, get headaches or fatigue for other reasons, and all patients in the trials also were taking other medicines.

Headache 27%
Dizziness 19%
Fatigue 16%
Nausea 12%
Sleepinesse 11%
Diplopia 9%
Tremor 6%
Vision Blurred 6%
Vomiting 5%
Ataxia (staggering) 4%
Abdominal pain 3%
Anxiety 3%
Constipation 3%
Stomach burning 3%
Back pain 3%
Vertigo (spinning dizziness) 3%

Patients taking Banzel have a small change of experiencing an allergic reaction known as the hypersensitivity syndrome, with fever, rash, fluid accumulation, swollen lymph nodes, liver injury and confusion.

Blood tests sometimes show abnormalities in patients taking Banzel. White blood counts were lowered in about 4% of people, though usually not to levels that would increase risk for infections. Electrocardiograms (a heart test) showed shortening of the QT intervals in some patients, which reflects an effect on conduction of the electrical signals through the heart. People who have the “Short QT syndrome” should not take Banzel.

Banzel increases blood phenytoin (Dilantin) concentrations by about 20%. Valproate (Depakote, Depakene) can increase blood concentrations of Banzel up to 70%. Banzel can lower levels of birth control hormones and make birth control pills less effective, especially if they are low-dose birth control pills.

Most possible drug interactions with Banzel have not yet been studied.

Pregnancy Category C, indicating that laboratory animals could have birth defects when their mothers were given Banzel during pregnancy. Whether or to what extent Banzel causes birth defects in humans is not presently known. This indicates that caution is advised, but the benefits of the medication may outweigh the potential risks.

Talk to your doctor or another health professional if you are pregnant or plan to become pregnant. We don't yet have enough information to be able to estimate the risk of various types of birth defects that might occur if Banzel is taken during pregnancy. We also don't know enough to compare the risk with Banzel to the risk with other seizure medicines.

The risk of birth defects is generally higher for women who take more than one AED and for women with a family history of birth defects.

Women who are capable of becoming pregnant should take at least 400 micrograms (0.4 mg) of folic acid (folate) daily to help prevent a type of birth defect called a neural tube defect. (The best-known of these is spina bifida, in which the spinal cord is not completely enclosed.) Women at high risk, such as those with a history of this kind of defect in a previous pregnancy, should take 4000 mcg (4 mg) daily, beginning before they become pregnant.

About 20% to 35% of women have seizures more often during pregnancy because of changes in hormones or changes in how their seizure medicine is handled by the body. The doctor may recommend checking the level of medication in the blood regularly during pregnancy so that the dosage can be adjusted as needed.

How much Banzel is passed through breast milk is not known for certain, but the way the body uses it suggests that probably Banzel does enter the milk. If you want to breast-feed your baby, check with your doctor about what seizure medicine would be best for you.

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